Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infinite Biomedical Technologies, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
128 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240884 | Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC | 2024-04-15 | 14 | 0 |
| K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | 2018-10-05 | 60 | 0 |
| K173571 | Element System with IBT Electrodes | Infinite Biomedical Technologies, LLC | 2018-03-21 | 121 | 0 |
| K101386 | VIGILANT EEG MONITOR MODEL VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | 2010-07-30 | 73 | 0 |
| K091963 | VIGILANT EEG MONITOR, VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | 2009-11-06 | 128 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda